Senior Pharmacovigilance Specialist

2 settimane fa


Milan, Italia Informatica Software A tempo pieno

Who are we?Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.Recruitment ProcessBrief Call : Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for youInterviews (the average number of interviews is 3 – the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunitiesCase study : Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem‑solving scenario, etc.As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience.We look forward to meeting youJob DescriptionJoin our team as Senior Pharmacovigilance Specialist (remote) . Start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast‑growing organization. Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in an industrial field, but above all, being an ambassador of our organization to clients, thanks to:Your interpersonal skills and ability to listen, in order to build a strong relationship of trust with our clients and fully understand their challenges and issues. Your curiosity and eagerness to learn, as we support over 1,000 clients from all sectors worldwide.ResponsibilitiesSupport end‑to‑end ICSR case processing activities for established products and rare disease portfolios.Perform data entry of adverse events in compliance with regulatory requirements.Conduct case validation and ensure accuracy of collected information.Perform quality checks of ICSR data, ensuring narrative and medical coding consistency.Distribute cases to commercial partners and regulatory authorities (EMA, MHRA, FDA) in a timely manner.Manage follow‑up activities for ongoing cases.Ensure compliance with global safety reporting workflows and timelines.Maintain accurate and thorough documentation of all case processing activities.QualificationsAt least 6 years in Pharmacovigilance with solid exposure to ICSR case processing.Experience in data entry, case validation, and follow‑up management.Experience in quality checking ICSR data and ensuring narrative/medical coding consistency.Experience in distributing cases to commercial partners and, ideally, regulatory authorities (EMA, MHRA, FDA).Experience with Argus Safety Database is preferred.Understanding of GVP Modules relevant to case processing.Knowledge of global safety reporting workflows and compliance requirements.Academic background: Life Sciences, Pharmacy, Medicine, or related field.Fluent English for global communication and safety documentation.Good knowledge of Italian language.Accuracy, attention to detail, and strong documentation skills.Ability to work with minimal supervision while maintaining high‑quality deliverables.What we offerAn international community, bringing together 110+ different nationalities.An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities.A robust training system with our internal Academy and 250+ available modules.A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.).Strong commitments to CSR, notably through participation in our WeCare Together program.Remote policy: Possibility to work fully remotely.Diversity and inclusionAmaris Consulting is proud to be an equal‑opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.#J-18808-Ljbffr



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